Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Fürst Peter, Gürtler Rainer, Gundert-Remy Ursula, Husøy Trine, Mennes Wim, Moldeus Peter, Oskarsson Agneta, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Boon Polly, Crebelli Riccardo, Di Domenico Alessandro, Filipič Metka, Mortensen Alicja, Van Loveren Henk, Woutersen Ruud, Giarola Alessandra, Lodi Federica, Riolo Francesca, Frutos Fernandez Maria Jose
EFSA J. 2019 Oct 30;17(10):e05868. doi: 10.2903/j.efsa.2019.5868. eCollection 2019 Oct.
The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of sulphuric acid (E 513) and its sodium (E 514), potassium (E 515), calcium (E 516) and ammonium (E 517) salts when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, E 514, E 515, E 516, E 517) are authorised food additives in the EU, in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. In the , mean exposure ranged from 0.4 mg sulphate/kg body weight (bw) per day in infants to 35 mg sulphate/kg bw per day in toddlers. The high percentile of exposure ranged from 3 mg sulphate/kg bw per day in adolescents to 68 mg sulphate/kg bw per day in toddlers. The Panel considered sulphates of low acute toxicity and there is no concern with respect to genotoxicity and carcinogenicity. The Panel noted that the exposure to sulphates at mean and 95th percentile in the as well as in the other scenarios, is far below the 300 mg/kg a dose that induced laxative effect in humans. Based on the toxicological database available, the Panel concluded that the exposure to sulphuric acid (E 513), sodium sulphate (E 514), potassium sulphates (E 515), calcium sulphate (E 516) and ammonium sulphate (E 517) does not raise a safety concern at the reported uses and use levels and there is no need for a numerical acceptable daily intake (ADI).
食品添加剂和调味剂专家委员会（FAF）提供了一项科学意见，重新评估硫酸（E 513）及其钠（E 514）、钾（E 515）、钙（E 516）和铵（E 517）盐作为食品添加剂使用时的安全性。专家委员会认为已有足够的暴露量和毒性数据。硫酸及其钠、钾、钙和铵盐（E 513、E 514、E 515、E 516、E 517）是欧盟根据（EC）No 1333/2008号法规附件二和附件三批准使用的食品添加剂。在[具体情况未给出]中，平均暴露量范围为婴儿每天0.4毫克硫酸盐/千克体重（bw）至幼儿每天35毫克硫酸盐/千克bw。暴露量的高百分位数范围为青少年每天3毫克硫酸盐/千克bw至幼儿每天68毫克硫酸盐/千克bw。专家委员会认为硫酸盐的急性毒性较低，并且在遗传毒性和致癌性方面无需担忧。专家委员会指出，在[具体情况未给出]以及其他情况下，平均暴露量和第95百分位数的硫酸盐暴露量远低于在人体中引起通便作用的300毫克/千克剂量。基于现有的毒理学数据库，专家委员会得出结论，在报告的使用方式和使用水平下，接触硫酸（E 513）、硫酸钠（E 514）、硫酸钾（E 515）、硫酸钙（E 516）和硫酸铵（E 517）不会引发安全问题，因此无需设定数值化的每日允许摄入量（ADI）。
